Kornimate/medical-research-clean huggingface dataset:
immune therapy in hr-positive/her2-negative metastatic breast cancer(enigma)-bctop-l-m02

Conditions: Breast Cancer; Metastatic Cancer

Summary: this study is a prospective, open-label, phase ii clinical study for patients with hr+/her2- advanced breast cancer.

patients with snf2 subtype of hr+/her2- advanced breast cancer confirmed by the department of pathology and key laboratory of breast cancer of fudan university affiliated cancer hospital are planned to be enrolled. five treatment arms were set up based on the whether they have exposed to cdk4/6 inhibitors before. the main purpose is to evaluate immune therapy in snf2 subtype of hr+/her2- advanced breast cancer and prepare for subsequent randomized controlled phase iii clinical studies with larger sample size.

Eligibility criteria:
inclusion criteria: * females ≥18 years and ≤ 75 years old; * histologically confirmed hr + / her2- invasive breast cancer (specific definition: immunohistochemical detection of er\> 10% tumor cell positive is defined as er positive, pr\> 10% tumor cell positive is defined as pr positive, er and / or pr positive is defined as hr positive; her2 0-1 + or her2 is ++ but negative followed by fish detection, no amplification, defined as her2 negative); * subtype of similarity network fusion-2 (snf-2) confirmed by the department of pathology and key laboratory of breast cancer of fudan university affiliated cancer hospital * locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer; * measurable disease according to response evaluation criteria in solid tumors v1.1 (recist v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions; * has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /l; platelet count \> 75x10ˆ9 /l, hemoglobin \> 9g/dl; * patients had received no previous chemotherapy or targeted therapy for metastatic disease * has adequate liver function and kidney function: serum creatinine * ecog score ≤ 2 and life expectancy ≥ 3 months; * participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. exclusion criteria: * treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease * symptomatic, untreated, or actively progressing cns metastases(glucocorticoids or mannitol needed to control symptoms); * significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months); * is pregnant or breast feeding; * malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ). * history of autoimmune disease * positive test for human immunodeficiency virus * active hepatitis b or hepatitis c * uncontrolled pleural effusion and ascites * thyroid dysfunction.

Keywords: first-line therapy
rotation medical bioinductive implant database registry

Conditions: Rotator Cuff Tear

Summary: the purpose of this clinical registry is to prospectively collect and compare preoperative and postoperative patient-reported data using validated shoulder-specific and health-related quality of life (qol) instruments during real-world use of the rotation medical bioinductive implant to treat rotator cuff tears.


Eligibility criteria:
inclusion criteria: 1. at least 21 years of age. 2. able and willing to provide voluntary consent to registry participation. 3. able to read, speak, and understand the english language. exclusion criteria: 1. hypersensitive to bovine-derived materials.

Keywords: partial-thickness full-thickness
understanding the risk of blood clots and bleeding in patients with hematological malignancies, hat study

Conditions: Acute Leukemia; Deep Vein Thrombosis; Hematopoietic and Lymphoid Cell Neoplasm; Hodgkin Lymphoma; Myeloproliferative Neoplasm; Non-Hodgkin Lymphoma; Plasma Cell Myeloma; Thrombocytopenia

Summary: this study evaluates the risks and experience of blood clots and bleeding in patients with blood cancers. while it is standard of care to use medications to reduce the risk of blood clots in hospitalized individuals, some patients with blood cancers have low platelet counts that can increase the concern for bleeding complications associated with these medications. at this time, the optimal management strategies for blood clots are not well known for patients with blood cancers. this pilot study evaluates additional information that could help doctors know which patients are at highest risk for blood clots.

primary objectives: i. determine the incidence of hemorrhage in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia. ii. determine recurrent or progressive venous thromboembolism in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia. secondary objectives: i. assess feasibility of database creation of patient and clinical characteristics regarding thrombosis and hemorrhage in hospitalized malignant hematology patients. ii. assess feasibility of patient enrollment and hemostatic laboratory collection pre, during and post treatment. iii. describe the impact of thrombocytopenia on resource utilization following thrombosis diagnosis (blood product administration, imaging studies performed, number of days hospitalized). iv. describe the impact of therapeutic anticoagulation vs prophylactic anticoagulation on resource utilization following thrombosis diagnosis (blood product administration, imaging studies performed, number of days hospitalized). v. define baseline hemostatic characteristics in hospitalized malignant hematology patients prior to chemotherapy and the association with thrombosis or hemorrhage. vi. describe changes in laboratory hemostatic characteristics pre-treatment, during treatment and post treatment. outline: patients' electronic health record are reviewed for 12 months and/or undergo collection of blood at pretreatment and on days 7, 28, 90, and 180.

Eligibility criteria:
inclusion criteria: * all unique patients, age \> 18 years old, admitted to the mayo clinic arizona hematology a and b service for initiation of 1.) new (or next line) chemotherapy, 2.) autologous stem cell transplant, or 3.) allogeneic stem cell transplant for a hematologic malignancy exclusion criteria: * solid tumor malignancy patients * age \< 18
neonatal neurologic intensive care network of china

Conditions: Neonatal Encephalopathy; Suspected Neonatal Encephalopathy

Summary: the purpose of this study is to create a neonatal neurologic biological big data center named neonatal neurologic intensive care network in china with neonatal systematic information, biological samples and genomics \& genetic data on neonates born with neonatal severe encephalopathy. it also can predict brain injury as cerebral function monitoring through big data and recommend appropriate treatment. in addition, the following samples will be collected in a bio-bank in for future studies: blood, urine, and cerebrospinal fluid (csf) samples.

the purpose of this study is to create a neonatal neurologic biological big data center named neonatal neurologic intensive care network in china with neonatal systematic information mainly including demographic, medical history, family condition, perinatal stage information, birth, growth \& feeding status, imaging, biological samples and genomics \& genetic data on neonates born with neonatal severe encephalopathy. it also can predict brain injury as cerebral function monitoring through big data and recommend appropriate treatment. there are seven children's hospitals from 6 provinces in china to join in the collaboration network in first recruiting. in addition, the following biological samples will be collected in a bio-bank for future studies: blood, urine, and cerebrospinal fluid (csf) samples.

Eligibility criteria:
inclusion criteria: 1. postnatal age \< or = 28 days 2. written informed consent of parent or guardian with one of the following items 3. hypoxic ischemic encephalopathy (hie) 4. hydrocephalus 5. hypotonia 6. interventricular hemorrhages 7. intracranial calcifications 8. intracranial hemorrhages 9. meningitis and other brain infections 10. metabolic diseases 11. microcephaly 12. neonatal stroke 13. spina bifid 14. cerebral arteriovenous malformations (avms) 15. congenital brain malformations exclusion criteria: 1. known other major congenital anomalies but not not neurologic disease. 2. failed to get sample or the volume of collected biosamples is not enough. 3. parents refuse consent.
comparison of two psychotherapy treatments for depressed women with a history of sexual abuse

Conditions: Depression

Summary: this study will compare the effectiveness of individual versus interpersonal psychotherapy in treating depressed women with a history of sexual abuse.

depression is a common but serious mental disorder that affects millions of people each year. depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affecting people's sleep patterns, concentration, and energy levels. women with a history of abuse are at an increased risk for developing symptoms of depression. however, treatments such as interpersonal psychotherapy and individual psychotherapy have been known to reduce symptoms of depression. this study will compare the effectiveness of individual and interpersonal psychotherapy in improving depressive symptoms and daily functioning in depressed women with a history of sexual abuse. participants in this study will undergo a two-part screening interview at the strong adult ambulatory clinic. this screening will include both written questionnaires and face-to-face interviews regarding any experiences of sexual or physical abuse; suicidal thoughts; family relationships; and current attitudes, thoughts, or feelings. participants who meet all criteria will then be randomly assigned to receive one of two treatments: interpersonal psychotherapy or individual psychotherapy, which is considered usual care. all treatment sessions will be held at the strong adult ambulatory clinic. participants assigned to receive interpersonal psychotherapy will attend weekly 50-minute sessions with a therapist. interpersonal psychotherapy will focus on current interpersonal stressors in daily life, such as difficulties in close relationships or at work. treatment will also help participants examine the relationship between their mood changes and interpersonal problems. participants assigned to receive individual psychotherapy will undergo cognitive-behavioral therapy, supportive counseling, or a combination of the two. participants will work with their therapists to decide upon a treatment plan designed to help changes in mood and other difficulties in daily life. the number and length of treatment sessions for this group will be determined on an individual basis. for all participants, evaluations consisting of questionnaires similar to those from the initial screening will be completed at mid-treatment, post-treatment, and 3 months after treatment.

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for unipolar major depressive disorder * history of childhood sexual abuse before the age of 18 * seeking outpatient psychotherapy treatment in a community mental health center exclusion criteria: * meets dsm-iv criteria for major depression with psychotic features, bipolar disorder, schizophrenia, or mental retardation * active alcohol or substance abuse within 3 months of study entry date

Keywords: major depressive disorder psychotherapy childhood sexual abuse trauma
clinical performance and safety of endopack® dt4-ebmca in acl reconstruction 24 months post-surgery : post-market clinical follow-up study

Conditions: ACL Rupture

Summary: anterior cruciate ligament (acl) injuries are among the most common sports-related knee traumas. the dt4-ebmca device, based on a quadrupled semitendinosus autograft technique, aims to provide effective and minimally invasive ligament reconstruction. this study evaluates its long-term performance and safety in routine clinical practice.


Eligibility criteria:
inclusion criteria: * patient implanted with dt4-ebmca in médipôle garonne for a total or partial rupture of the anterior cruciate ligaments * patient having answer to ikdc and koos pre-operative * patient having received information and signed informed consent exclusion criteria: * patients who refuse to participate * patients unable to understand questionnaires * patients who, at the time of surgery, present the contraindications and factors likely to jeopardize the success of the implant contained in the ifu : * acute or chronic, local or systemic infections; * severe muscular, neurological or vascular impairments affecting the extremity concerned; * bone destruction or poor bone quality that may affect device stability; * any concomitant condition that may affect device function; * patients with sensitivity to device material that may cause allergic reactions. * severe osteoporosis; * significant deformity, congenital dislocation; * local bone tumours; * systemic or metabolic disorders; * infectious diseases; * substance abuse and/or tendencies to abuse drugs or medication; * obesity; * unsupervised intense physical activity.
prf membrane and recovery after periapical surgery: a 3d imaging study

Conditions: Periapical Diseases; Radicular Cyst; Granuloma; Postoperative Complications; Pain, Postoperative

Summary: the goal of this clinical trial is to determine whether a prf (platelet-rich fibrin) membrane helps improve recovery after periapical surgery in adults. the main questions it seeks to answer are: does the use of a prf membrane reduce swelling and pain after surgery? does the use of a prf membrane improve healing as observed on 3d imaging? researchers will compare the outcomes of participants who receive a prf membrane during surgery with those who do not, to assess whether the prf membrane improves recovery. participants will: undergo periapical surgery with or without the use of a prf membrane. have swelling and pain assessed at specific time points after surgery. participate in 3d imaging scans to evaluate healing. participants will: undergo periapical surgery with or without the use of a prf membrane. have swelling and pain measured at specific time points after surgery. take part in 3d imaging scans to evaluate healing.


Eligibility criteria:
inclusion criteria: * adults aged 20-65 years, both male and female. * diagnosed with periapical disease, including periapical cysts or granulomas. * requiring periapical surgery as part of their treatment plan. * presenting a tooth needing endodontic surgery with periradicular lesions of strictly endodontic origin. * size of the bone crypt between 6 mm and 12 mm. * non-surgical retreatment considered unfeasible or previously failed. * apical root canal free from posts over a length of at least 6 mm. * adequate coronal restoration without coronal leakage. * willing and able to provide written informed consent. * capable of attending follow-up visits and participating in required assessments. * maxillary and mandibular teeth limited to the 2nd premolar to 2nd premolar regions. * without general medical contraindications for oral surgical procedures. exclusion criteria: * patients with systemic conditions affecting healing, such as: * • uncontrolled diabetes mellitus. * • autoimmune disorders. * • chronic inflammatory diseases. * pregnant or breastfeeding individuals. * use of medications or therapies that may interfere with healing, including: * • bisphosphonates. * • immunosuppressants. * • radiotherapy. * • oncological therapies (e.g., chemotherapy, immunotherapy). * requires antibiotic prophylaxis or therapy. * history of allergies or adverse reactions to blood-derived products. * neuropsychiatric disorders. * active infection or severe periodontal disease in the surgical area. * periodontal probing depths greater than 5 mm. * moderate to severe periodontal bone loss. * vertical root fractures. * perforation of the furcation area or root canal, except for the apical area. * smokers or individuals unwilling to refrain from smoking during the study period. * participation in another clinical trial within the last 30 days. * absolute or relative contraindications for surgery.
the use of peripheral blood specimens from patients suspected of having sars-cov-2 infections in research studies intended to support the development of covid-19 detection methods, treatments, and/or vaccines

Conditions: SARS-CoV-2

Summary: invivoscribe, inc. and its wholly owned subsidiary labpmm, llc are collecting peripheral blood specimens from patients with suspected sars-cov-2 viral infections. these donors will be from a population of patients who are already providing nasal pharyngeal (np) swab samples in universal transport media (utm) for covid-19 testing at labpmm llc. specimens meeting this research protocol's inclusion criteria may be evaluated with various molecular techniques in order to identify nucleic acid sequences, antibodies, and/or antigens with the potential of being used to develop novel sars-cov-2 detection methods and covid- 19 treatments and/or prevention methods (e.g. drug or vaccine development).

this research protocol describes the collection and analysis of peripheral blood samples to: * identify nucleic acid sequences that may be used aide in the development of sarscov- 2 detection methods. * identify antibodies that may be used aide in the development of sars-cov-2 detection methods. * identify antigens that may be used aide in the development of sars-cov-2 detection methods. -identify nucleic acid sequences that may be used aide in the development of covid- 19 treatments and/or vaccines. * identify antibodies that may be used aide in the development of covid-19 treatments and/or vaccines. * identify antigens that may be used aide in the development of covid-19 treatments and/or vaccines.

Eligibility criteria:
inclusion criteria: * from patients suspected of sars-cov-2 viral infections. * from patients who have had covid-19 testing prescribed by their treating physicians. * from patients whose covid-19 test specimen was sent to labpmm, llc for testing exclusion criteria: * there are no exclusion criteria related to age, gender, race, ethnicity, geography, and/or other medical conditions.
ventilation distribution during spontaneous breathing in healthy newborn infants

Conditions: Spontaneous Breathing; Full-Term Neonate

Summary: electrical impedance tomography (eit) is an evolving monitoring tool for respiratory support in neonatal and pediatric intensive care. in this observational study basic eit parameters will be measured on 20 healthy newborn infants during spontaneous breathing and assess the effect of position changes in ventilation distribution.

neo sensorbelts will be used to observe ventilation distribution in healthy newborn infants during quiet spontaneous breathing. child's position will be changed 5 times every 10 minutes in a random order. positions observed will be: left lateral, right lateral, supine, prone face to left, prone face to right and supine with the bed tilted 30 degrees. total duration for the recording will be 1 hour.

Eligibility criteria:
inclusion criteria: * written informed consent from a parent or legal guardian * gestational age 37+0 - 42+0 weeks * uneventful follow-up in maternity ward exclusion criteria: * respiratory distress * admission to nicu * thorax skin lesions * prior participation in this study
prevention of post traumatic stress disorder by early treatment

Conditions: Post-traumatic Stress Disorder

Summary: to prospectively evaluate the effect of early treatment (cognitive therapy (ct), cognitive-behavioral therapy (cbt) and escitalopram (ssri) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events.

consecutive civilian trauma survivors will be contacted, by phone, within five days of admission to hadassah university hospital in jerusalem and asked about their early psychological responses to the event. a short telephone interview will be administered to consenting subjects, to evaluate the presence of acute stress disorder (asd). subjects with asd (full or partial) and those who so desire will be invited to clinical assessment, which will take place within the next two weeks. survivors with significant symptoms of post-traumatic stress disorder will be randomized to five arms of twelve-week long treatment: cbt, ct, ssri/placebo and waiting list (wl) and start treatment immediately. subjects will be allowed to decline one form of therapy. wl subjects will start therapy 12 weeks later. all subjects who had clinical interview will be interviewed again at four and seven months - and 14 months following trauma (phone interview).

Eligibility criteria:
inclusion criteria: * adults survivors of traumatic events exclusion criteria: * traumatic brain injury * lifetime psychosis * life time (prior) ptsd * medical conditions forbidding ssris

Keywords: traumatic events post-traumatic stress disorder treatment (psychological) treatment (pharmacological) prevention ssris